Cambridge Healthtech Training Seminars
August 6-7, 2015
DAY 1 2:00-5:30 pm • DAY 2 8:30 am - 4:30 pm
(TS8) Introduction to Analytical Method Development and Validation
for Therapeutic Proteins
This course is a panoramic review of analytical method development and validation for therapeutic proteins, including antibodies and enzymes. It is intended for scientists working on therapeutic proteins in Analytical Development, Quality Control, Product Development or related functional areas. It starts with basic knowledge of work on therapeutic proteins: manufacturing of proteins drugs, regulatory affair knowledge and protein chemistry. It then discusses fundamentals and practical aspects of commonly used analytical methods for proteins, including methods for structure elucidation, glycan characterization, biophysical characterization, potency measurement, purity and impurity analysis. The course concludes with the strategy and common practice in method validation and method transfer, including regulatory compliance at different stages of product development, application of DOE and QbD. The course emphasizes practical applications, real-world examples and useful tips.
- Manufacturing process for therapeutic proteins
- Basic regulatory affair knowledge
- Basic protein chemistry: structure, PTM and degradations
- Protein quantitation
- Gel electrophoresis and Western Blot
- Capillary electrophoresis (cZE, cIEF, CGE, iCE280, Labchip)
- Chromatography methods (RP, IEX, SEC, UPLC)
- Mass spectrometry
- Protein structure elucidation (MS/MS, peptide mapping , AAA, terminal sequencing)
- Glycosylation and glycan characterization
- Biophysical characterizations (CD, FT-IR, DSC, fluorescence)
- Protein aggregation and subvisible particles (SEC-MALS, AUC, FFF, LO, MFI)
- Host cell proteins assay and host cell DNA assay (immunoassay, threshold assay, qPCR)
- Bioassay (enzymatic activity, binding and cell-based assay)
- Method validation at different stages of product development
- Strategy and common pitfalls of method transfer
- Application of QbD and DOE
- Gain a complete picture of analytical method development and validation process
- Gain a basic understanding of commonly used analytical methods for proteins
Who Should Attend
- Analytical development scientists, process development scientists, QC analysts, regulatory affair managers, project managers and quality assurance managers
Jichao (Jay) Kang, Ph.D., RAC, Director, Analytical and Formulation Development, Patheon Biologics
Dr. Jichao Kang holds a Ph.D. in Pharmaceutics and has been working on characterization, method development and validation and formulation for protein therapeutics since 1995. He is an accomplished researcher with over 15 peer-reviewed journal articles and book chapters, several patents and numerous conference presentations. The proteins he has worked on extensively include cytokines, antibodies, enzymes and protein conjugates. He is a key contributor in dozens of IND/IMPD and BLA/MAA filings. He is currently the Director of Analytical and Formulation Development at Gallus BioPharmaceuticals NJ, LLC, one of the leading CMOs for biologics, and held the same position at Laureate BioPharma before it was acquired by Gallus. Prior to Laureate, he was the department head of Analytical Development at Auxilium Pharmaceuticals, Inc., and was a key contributor in Auxilium’s successful marketing application of Xiaflex in both U.S. and EU. He also worked in MedImmune, PDL, and Neose Technologies.
Each CHI Training Seminar offers 1.5 Days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch is “on your own”.
Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed no additional books will be available.
Those not attending a full training seminar, but who are registered for other tracks on those days of the conference, may participate in the training seminar sessions. We ask that those joining the seminars while they are in progress enter the room only during scheduled break periods to avoid disrupting the class in progress.